Study Purpose:

To determine whether concurrent pyridoxine therapy can prevent the development of hand-foot syndrome (HFS) in patients being treated with capecitabine.

Intervention Characteristics/Basic Study Process:

Chemotherapy-naïve patients with gastrointestinal (GI) tract cancers who were scheduled for capecitabine-containing chemotherapy were randomly assigned to concurrent oral pyridoxine (200 mg per day) or placebo. Patients were stratified by chemotherapy regimen and monitored until development of HFS with a National Cancer Institute (NCI) common toxicity criteria of grade 2 or worse, or capecitabine-containing chemotherapy ended. Patients in the placebo group who developed grade 2 or worse HFS were randomly assigned again to received pyridoxine or placebo in the next chemotherapy cycle to determine whether pyridoxine could improve HFS.

Sample Characteristics:

The study reported on a sample of 360 patients with GI tract cancers.

Median patient age was 56 years.

The sample was 67% male and 33% female in the pyridoxine group, and 58% male and 42% female in the placebo group.

Most patients had colon cancer and were scheduled for adjuvant capecitabine monotherapy. The next largest group comprised patients with stomach cancer who were receiving palliative capecitabine and cisplatin, or docetaxel, capecitabine, and cisplatin.

Patients in both arms received a median of six cycles of chemotherapy.

Setting:

The site and setting types were not specified.

Phase of Care and Clinical Applications:

Patients were undergoing the active treatment phase of care.

Study Design:

This was a randomized, double-blinded, placebo-controlled trial.

Measurement Instruments/Methods:

Kaplan-Meier curves

NCI Common Terminology Criteria for Adverse Events (CTCAE), version 2.0

Results:

Randomization of the 44 patients in the placebo group with grade 2 or worse HFS to placebo or pyridoxine for the next cycle resulted in no significant difference in the proportion showing improvement of HFS.

Conclusions:

Pyridoxine is not effective in the prevention of capecitabine-associated HFS.

Limitations:

This trial did not include pathophysiologic analysis, which could have provided additional information on the pathogenesis of capecitabine-induced HFS.

Nursing Implications:

Pyridoxine prophylaxis was shown to have no effect on reducing the development or severity of HFS.